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EC number: 226-546-1 | CAS number: 5422-34-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted similar to a appropriate OECD test guideline and in compliance with GLP. Only limited information on the test material is available. No analytical purity of the test substance is given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 28 July 2015
- Deviations:
- yes
- Remarks:
- The test material was applied to the intact/abraded skin for 24 hours under occlusive coverage and the evaluation of skin irritating effects were only performed 24 and 72 h. Relative humidity/temperature exceeded guideline specific standard values
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-2-hydroxyethyllactamide
- EC Number:
- 226-546-1
- EC Name:
- N-2-hydroxyethyllactamide
- Cas Number:
- 5422-34-4
- Molecular formula:
- C5H11NO3
- IUPAC Name:
- N-2-hydroxyethyllactamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2300 – 2800 g
- Housing: animals were housed in grid bottomed metal cages
- Diet: pelleted rabbit diet (Dalgety Spillers Limited), ad libitum
- Water: mains drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 – 24
- Humidity (%): 80 – 90
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 hours
Reading time points: 24 and 72 h (post start of exposure) - Number of animals:
- 6 females
- Details on study design:
- TEST SITE
- Area of exposure: Immediately before dosing the left flank of the animals' back was lightly abraded in a criss-cross pattern using the point of a 25 x 0.6 mm sterile disposable hypodermic needle. The abrasions were sufficiently deep to damage the stratum corneum but not to penetrate the dermis. The skin of the right flank remained intact.
- Type of wrap if used: The undiluted test material was placed over two 2.5 cm square surgical lint pads attached to a length of 5 cm wide sleek plastic adhesive wrapping. The lint squares were then placed in contact with the animals skin, one lint suare with abraded skin and one lint square in contact with intact skin, and secured in position by the attached sleek adhesive tape. The trunk of the animal was then encircled with a length of Elastoplast elastic adhesive bandage 7.5 cm wide.
REMOVAL OF TEST SUBSTANCE
- Washing: Excess test material remaining on the skin was removed by gentle wiping with cotton wool soaked in warm water.
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Well defined erythema (grade 2) were observed at two abraded and two intact skin sites and very slight erythema (grade 1) was apparent at two abraded and two intact treatment sites following the twenty four hour treatment period. Very slight edematous (grade 1) reaction was apparent at one abraded skin site and at one intact skin site. The irritation described declined rapidly, very slight irritation of the treated skin remained in one animal only on termination of the study. The calculated mean values for erythema and edema were 0.67 and 0.11, respectively.
Any other information on results incl. tables
Table 1: Results of skin irritation studies (intact skin)
Observation time |
Rabbit no. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
24 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
2 |
1 |
2 |
0 |
48 ha) |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
2 |
1 |
2 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0 |
0 |
0.67 |
0 |
0 |
0 |
0.67 |
0 |
1.33 |
0.67 |
1.33 |
0 |
a) No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
Table 2: Results of skin irritation studies (abraded skin)
Observation time |
Rabbit no. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
24 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
2 |
1 |
2 |
0 |
48 ha) |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
2 |
1 |
2 |
0 |
72 h |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0 |
0 |
1 |
0 |
0 |
0 |
0.67 |
0 |
1.33 |
0.67 |
1.33 |
0 |
a) No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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